Two-year outcomes of surgeon-tailored trans obturator tape for female stress urinary incontinence: a randomized, comparative, trial with traditional trans obturator tape.

BACKGROUND: Previously, we presented the short-term outcomes of surgeon-tailored mesh in patients with SUI undergoing TOT. In this report, we aim to highlight the two-year outcomes of surgeon tailored mesh in terms of subjective and objective cure rates, as well as late complications. METHODS: We performed a randomized, open-label comparative trial that recruited women with SUI who were scheduled to undergo TOT. Eligible patients were randomly allocated in a 1:1 ratio to receive traditional TOT mesh or surgeon-tailored polyethylene mesh. All patients were followed up for two years. RESULTS: At the end of the follow-up, there were 13 women in the traditional TOT mesh group and 14 patients in the surgeon-tailored polyethylene mesh group. Concerning the primary outcome of the present study, the cure rate was 100% in the surgeon-tailored polyethylene mesh (n = 14) and 92.9% in the traditional TOT mesh group (p = 0.39). One woman reported improved symptoms in the traditional TOT mesh group. There were no reported failures in both groups. Concerning safety, the incidence of de novo urgency was 0% in the surgeon-tailored polyethylene mesh group, compared to 7.1% in the traditional TOT mesh group (p = 0.34). None of the women in both groups reported mesh erosions, dyspareunia, or need for reoperation. CONCLUSION: Surgeon-tailored mesh for patients undergoing TOT is a cost-effective technique, which has comparable long-term outcomes, in terms of cure rate and complications, to the traditional costly meshes. Larger multicentre studies should confirm our results.

Single Port Robotic Surgery in Urology.

PURPOSE: To provide a comprehensive review on the new da Vinci SP (single port) robotic surgical system. The published literature to date within urology and a description of the new system will be discussed. FINDINGS: There are currently no high-quality published studies with the SP robotic system. All studies are case series, many with 10 or fewer patients. However, all studies have found the SP system to be safe and feasible in performing most urological procedures. Renal and pelvic surgery using the SP robotic system is safe and feasible in the hands of expert robotic surgeons. Long-term, high-quality data is lacking. While the current high price and the learning curve will limit the SP systems' use in many health care systems, new updates and the release of robotic surgical systems from other developers may help drive down costs and encourage uptake.

Decreasing operating room costs via reduction of surgical instruments.

BACKGROUND: Rising costs in health care demand waste reduction and improved efficiency throughout the hospital. Surgeons have an important role in regard to the number of instruments used in procedures. Previous studies have demonstrated instrument maintenance and sterilization cost approximately $0.51-$0.77 per instrument and found that only 13-21.9% of instruments opened are used. OBJECTIVE: The aim of the study was to reduce the surgical trays so that more than 50% of the instruments are used leading to a cost savings of at least 20% per tray. This was begun with the minor urology tray which is primarily used for orchiopexy and hernia repair. STUDY DESIGN: This was a single-site, prospective study. A Plan, Do, Study, Act cycle was used. A multidisciplinary team including urologists, surgical technicians, and a central processing department representative was developed. Inguinal orchiopexy with hernia, scrotal orchiopexy, and inguinal hernia cases were randomly chosen to count the total instruments used in each procedure. The exact instruments were recorded every third case to obtain a sample of variable patients and surgeon preferences. The percentage of utilization was calculated, and a list of instruments used was created. Those not used or used less than 20% of the time were removed. The new list was reviewed with the option to add or eliminate instruments. The approved reduced list was then implemented as the genitourinary (GU) minor tray. Finally, the instruments used in 10 inguinal orchiopexy with hernia cases, 10 scrotal orchiopexy cases, and 10 inguinal hernia cases were counted. The percentage of utilization was calculated. This process was then replicated in other surgical trays. RESULTS: The GU minor instrument tray was reduced from 57 to 35 instruments, a 39% reduction in size. Scrotal orchiopexy uses the least instruments (16.9), a utilization percentage of 48.3% after reduction. Inguinal orchiopexy with hernia repair uses the most number of instruments (25.1) with 71.7% utilization after reduction, compared with 43% before reduction. Using the cost analysis performed by Stockert and Langerman, $11.22 was saved during each procedure; this translates to a cost savings of $3489.42 annually. After reduction, only 10% of the cases required an extra instrument to be opened. Three other surgical trays were reduced using the same method, yielding a potential savings of $14,588. DISCUSSION: Baseline data demonstrates low average instrument utilization rangin from 21.1% to 49.1% per case. It is estimated that each instrument costs from $0.51 to $3.19. Decreasing the number of instruments opened with each surgical procedure is a viable way to decrease costs and efficiency in the operating room. CONCLUSIONS: Initially, the GU minor tray was successfully reduced by 39%, followed by the other surgical trays. A multidisciplinary approach is critical for success. This study showed an excellent opportunity for cost savings by decreasing reusable waste in the operating room.

Assessing the costs of disposable and reusable supplies wasted during surgeries.

BACKGROUND: The management of disposable and reusable supplies might have an impact on the cost efficiency of the Operating Room (OR). This study aimed to evaluate the cost and reasons for wasted supplies in the OR during surgical procedures. METHODS: We conducted an observational and prospective study in a French university hospital. We assessed the cost of wasted supplies in the OR (defined by opened unused devices), the reasons for the wastage, and the circulator retrievals. At the end, we assessed the perception of surgeons and nurses relative to the supply wastage. RESULTS: Fifty routine procedures and five non-scheduled procedures were observed in digestive (n = 20), urologic (n = 20) and gynecologic surgery (n = 15). The median cost [IQR] of open unused devices was €4.1 [0.5; 10.5] per procedure. Wasted supplies represented up to 20.1% of the total cost allocated to surgical supplies. Considering the 8000 surgical procedures performed in these three surgery departments, the potential annual cost savings were 100 000€. The most common reason of wastage was an anticipation of the surgeon's needs. The circulating nurse spent up to 26.3% of operative time outside of the OR, mainly attending to an additional demand from the surgeon (30%). Most of the survey respondents (68%) agreed that knowing supply prices would change their behavior. CONCLUSIONS: This study showed the OR is a major source of wasted hospital expenditure and an area wherein an intervention would have a significant impact. Reducing wasted supplies could improve the cost efficiency of the OR and also decrease its ecological impact.

Robotic surgery: new robots and finally some real competition!

PURPOSE: For the last 20 years, the predominant robot used in laparoscopic surgery has been Da Vinci by Intuitive Surgical. This monopoly situation has led to rising costs and relatively slow innovation. This article aims to discuss the two new robotic devices for laparoscopic surgery which have received regulatory approval for human use in different parts of the world. MATERIALS: A short description of the Senhance Surgical Robotic System and the REVO-I Robot Platform and their pros and cons compared to the Da Vinci system is presented. A discussion about the differences between the three robotic systems now in the market is presented, as well as a short review of the present state of robotic assistance in surgery and where we are headed.

Updates in Urologic Robot Assisted Surgery.

Modern robotics is an advanced minimally invasive technology with the advantages of wristed capability, three-dimensional optics, and tremor filtration compared with conventional laparoscopy. Urologists have been early adopters of robotic surgical technology: robotics have been used in urologic oncology for more than 20 years and there has been an increasing trend for utilization in benign urologic pathology in the last couple of years. The continuing development and interest in robotics are aimed at surgical efficiency as well as patient outcomes. However, despite its advantages, improvements in haptics, system size, and cost are still desired. This article explores the current use of robotics in urology as well as future improvements on the horizon.

Role of Robotics in Children: A brave New World!

CONTEXT: The key in the evolution towards minimally invasive surgery is the availability of appropriate equipment, especially when procedures involve children. While robotic procedures in adults continue to struggle to prove measurable advantages compared with open or classical laparoscopic ones, the use of the robotic platform (RP) in pediatric urology is steadily increasing. OBJECTIVE: To review the contemporary literature regarding the use of robotic-assisted (RA) urologic interventions in children. EVIDENCE ACQUISITION: A nonsystematic review of the literature was conducted through PubMed database between 2002 and 2017, with an emphasis on large series. EVIDENCE SYNTHESIS: A few major challenges must be considered before using the RP in children: anesthesia, placement of trocars, and technical difficulties related to small space. To date, only the robot-assisted pyeloplasty is recognized as safe and efficient with an equivalent outcome compared to the open or classical laparoscopy; this was supported by large multicentric studies, which are not available for most of the other procedures. CONCLUSIONS: RA procedure in children has been proven safe and effective. Still in its infancy, further data over time is likely to prove different RA procedures to be equivalent to open or laparoscopy in terms of outcome. PATIENT SUMMARY: The advent of the robotic platform means an evolution towards minimizing surgical trauma for the child. Currently, the available platforms designed for adults are adapted to work in children. However, it might be expected in the future that new technologies will improve the technical possibilities to improve the robotic platform for minimally invasive surgery in children. To date, a few applications are considered safe and efficient (in experienced hands), considering that the team has to be aware of some challenges to overcome regarding anesthesia, material, and technique adaptation to the patient. The most accepted robotic applications in children comprises of the robot-assisted pyeloplasty, hemi-nephrectomy, and ureteric reimplantation.

Semi-Automatic Electronic Stent Register: a novel approach to preventing ureteric stents lost to follow up.

BACKGROUND: Ureteric stents are indispensable tools in modern urology; however, the risk of them not being followed-up once inserted poses medical and medico-legal risks. Stent registers are a common solution to mitigate this risk; however, manual registers are logistically challenging, especially for busy units. METHODS: Western Sydney Local Health District developed a novel Semi-Automatic Electronic Stent Register (SAESR) utilizing billing information to track stent insertions. To determine the utility of this system, an audit was conducted comparing the 6 months before the introduction of the register to the first 6 months of the register. RESULTS: In the first 6 months of the register, 457 stents were inserted. At the time of writing, two of these are severely delayed for removal, representing a rate of 0.4%. In the 6 months immediately preceding the introduction of the register, 497 stents were inserted, and six were either missed completely or severely delayed in their removal, representing a rate of 1.2%. A non-inferiority analysis found this to be no worse than the results achieved before the introduction of the register. CONCLUSION: The SAESR allowed us to improve upon our better than expected rate of stents lost to follow up or severely delayed. We demonstrated non-inferiority in the rate of lost or severely delayed stents, and a number of other advantages including savings in personnel costs. The semi-automatic register represents an effective way of reducing the risk associated with a common urological procedure. We believe that this methodology could be implemented elsewhere.

[Assessment of the learning curves for intravesical adenoma morcellation using Piranha© device during endoscopic enucleation]. / Analyse de la courbe d'apprentissage de la morcellation intravésicale réalisée avec le système Piranha© au cours de l'énucléation endoscopique.

INTRODUCTION: Morcellation of intravesical adenoma (MIA) is an important part of the endoscopic enucleation procedure. The aim of this study was to analyse the learning curve of the MIA during endoscopic enucleation of the prostate. MATERIAL: We conducted a prospective study of the first 90 patients treated by endoscopic enucleation of the prostate by a single surgeon without previous experience of MIA. The population was divided into 3 consecutive groups of 30 patients. MIA was performed with the morcellator Pinranha (Wolf) and disposable blades (Vmax©). The criteria selected to assess the progress of MIA over time were: duration of MIA (min), the intraoperative complications encountered during MIA and weight morcelleted tissue. The efficacy of MIA was assessed with the ratio weight specimen/MIA duration (min/g) over time. RESULTS: The three groups were comparable in terms of age, ASA score of prostate volume. A significant decrease in the duration of MIA was found between groups 1 and 2 (12 versus 5.5min, P<0.0001), to reach a plateau in the group 3 (3min). A significant increase in the efficiency of MIA was found between group 1 and 2 (5.5 versus 11g/min, P<0.0001), to reach a plateau in the group 3 (20g/min). Bladder injuries were limited (7.7%), superficial and encountered in the early learning phase. CONCLUSION: In our experience, the MIA required a learning curve estimated between 30 and 60 procedures. LEVEL OF EVIDENCE: IV.

Cost effectiveness and robot-assisted urologic surgery: does it make dollars and sense?

INTRODUCTION: The introduction of the robotic surgical platform has led to distinct changes in practice patterns and the utilization of minimally invasive surgery in urology. While use of the robotic system is associated with improvements in perioperative outcomes such as estimated blood loss and hospital stay, there are significant fixed and variable costs with the purchase, maintenance and use of the robotics system that has led many authors to investigate the cost effectiveness of robotic urologic surgery. We sought to examine the best current available evidence for the cost effectiveness of robotic urologic surgery. EVIDENCE ACQUISITION: Comprehensive electronic literature searches were conducted without language restriction to identify reports of published studies within PubMed/Medline, SCOPUS and Web of Science. Relevant articles were examined and reference lists cross referenced to find additional pertinent publications. EVIDENCE SYNTHESIS: PubMed literature searches of "robot urology cost" (304 articles) "robotic prostatectomy cost" (215 articles), "robotic nephrectomy cost" (87 articles), "robotic cystectomy cost" (44 articles) and "robotic pyeloplasty cost" (41 articles) were initially reviewed in abstract form to find appropriate articles for inclusion. Given that robotic cystectomy (559 articles), robotic pyeloplasty (344 articles) robotic retroperitoneal lymph node dissection (59 articles) are less frequently performed than robotic prostatectomy, all available articles published from January 1st 2000 until July 31st 2016 were reviewed for potential inclusion. After excluding duplicates, appropriate articles were pulled for full text review. 49 articles were used for the final analysis. CONCLUSIONS: The available literature on the cost effectiveness of robotic urologic surgery is somewhat limited by heterogeneity of research methods, local cost variations and methods for determining costs associated with surgical outcomes. The introduction of the robotic surgical platform has led to a dramatic change in the availability and utilization of laparoscopic surgery and is associated with both favorable perioperative outcomes as well as significantly greater fixed costs related to instrumentation and equipment expenses. Well-designed trials comparing open and robotic approaches in the contemporary era of widespread robotic adoption with quality of life and validated economic metrics will be necessary to provide evidence for continued use of this valuable technology.

Surgical treatment of stress urinary incontinence-trans-obturator tape compared with tension-free vaginal tape-5-year follow up: an economic evaluation.

OBJECTIVE: To conduct an economic evaluation of the use of trans-obturator tape (TOT) compared with tension-free vaginal tape (TVT) in the surgical treatment of stress urinary incontinence in women. DESIGN: Cost-utility and cost-effectiveness analyses from a public-payer perspective, conducted alongside a randomised clinical trial. SETTING: Health services provided in Alberta, Canada. SAMPLE: A total of 195 women participated in the randomised clinical trial, followed to 5 years postsurgery. METHODS: Comparisons were undertaken between study groups for cost and two health-outcome measures. Multiple imputation was used to estimate the 14% of missing data. Bootstrapping was used to account for sampling uncertainty. Sensitivity analyses were based on complete case analyses and the removal of a TVT patient with extreme health service cost. MAIN OUTCOME MEASURES: The 15D instrument was used to calculate quality-adjusted life-years (QALYs) for the primary analysis. Absence of serious adverse events was also analysed. Costs were based on inpatient and outpatient hospital use data and practitioner fee-for-service claims data. RESULTS: The TOT group had a nonsignificant average saving of $2368 (95% CI -$7166 to $2548) and incremental gain of 0.04 QALYs (95% CI -0.06 to 0.14) compared with TVT. TOT was dominant in over 71% of bootstrap replications and cost-effective over a wide range of willingness-to-pay. Cost-effectiveness analysis using the absence of an serious adverse events provided similar results. CONCLUSION: The results suggest that TOT is cost-effective compared with TVT in the treatment of stress urinary incontinence. TWEETABLE ABSTRACT: The results of a 5-year cost-effectiveness analysis suggest that trans-obturator tape is cost-effective compared with tension-free vaginal tape in the treatment of stress urinary incontinence.

Integrated HTA-FMEA/FMECA methodology for the evaluation of robotic system in urology and general surgery.

OBJECTIVES: The following study proposes and tests an integrated methodology involving Health Technology Assessment (HTA) and Failure Modes, Effects and Criticality Analysis (FMECA) for the assessment of specific aspects related to robotic surgery involving safety, process and technology. METHODS: The integrated methodology consists of the application of specific techniques coming from the HTA joined to the aid of the most typical models from reliability engineering such as FMEA/FMECA. The study has also included in-site data collection and interviews to medical personnel. RESULTS: The total number of robotic procedures included in the analysis was 44: 28 for urology and 16 for general surgery. The main outcomes refer to the comparative evaluation between robotic, laparoscopic and open surgery. Risk analysis and mitigation interventions come from FMECA application. CONCLUSIONS: The small sample size available for the study represents an important bias, especially for the clinical outcomes reliability. Despite this, the study seems to confirm the better trend for robotics' surgical times with comparison to the open technique as well as confirming the robotics' clinical benefits in urology. More complex situation is observed for general surgery, where robotics' clinical benefits directly measured are the lowest blood transfusion rate.

Assessment of perioperative, early, and late postoperative complications of the inside-out transobturator tape procedure in the treatment of stress urinary incontinence..

OBJECTIVE: To evaluate the complications of urinary incontinence surgery with transobturator tape (TVT-O) system and to describe its diagnosis and management. MATERIALS AND METHODS: A total of 156 patients who were diagnosed as having stress incontinence and mixed incontinence with stress predominance underwent a TOT operation under spinal anesthesia by one surgeon or two surgeons (MB, AEY) from the team. TVT-obturator inside out material was used in the operation. Urodynamic tests and pad tests were done on all the patients. This is a prospective and retrospective study of the complications of TVT-O. The operation was performed under regional anesthesia, as described by Deval et al. Patients were excluded from the study if they had been operated under general or local anesthesia, had undergone any vaginal operations except for anterior repair (cystocele), wanted to have a baby, had severe systemic diseases or had been diagnosed as having urge incontinence in urodynamic tests. These situations may affect the rate of complications, the authors also excluded slings that had materials other than monofilament polypropylene, and patients who were suspected of having neurologic bladder conditions. The bladder and urethra were evaluated using cystoscopy. The durations of the TOT procedure, cystoscopy, and if performed, the cystocele operation, were recorded. Perioperative, early, and late postoperative complications were analyzed by follow-up visits (after two months to four years). RESULTS: Of the 156 patients included in the study, 100 (64.1%) had pure stress urinary incontinence and 56 (35.9%) had mixed incontinence, 20 (12.8%) had previous incontinence surgery. The mean duration of follow up was 30.3 ± 7.4 (range 17-42) months. The mean age of the patients was found to be 48.43 ± 6.24 years (range 42-68). The mean parity of the patients was 5.24 ± 2.86 (range 2-13), and mean body mass index was found to be 23.7 ± 4.8. Mean maximum detrusor pressure was 10.30 ± 4.08 and the mean ALP value was 80.80 ± 25.57. Mean operative time was found to be 13.8 ± 5.16 min in patients who underwent only TOT and TOT-anterior repair. Vaginal injury including to the lateral fornix (4.4%), hemorrhaging of more than 200 ml (3.2%), vascular damage (1.9%), hematoma on the leg (1.9%), hemorrhaging of more than 500 ml (0.064%), and bladder perforation (1.2%) were detected as perioperative complications. Urethral injury and perioperative nerve and intestinal injury did not occur. The most common complication in early postoperative period was inguinal pain extending the legs (30.7%), followed by headaches (23.7%), fever (12.8%), urinary tract infection (5.7%), and urinary retention (3.2%), respectively. Late postoperative complications included vaginal erosion (4.4%), de novo urge incontinence (8.9%), de novo dyspareunia (7.1%), perineal pain (4.4%), and worsening urgency (8.9%). CONCLUSION: Although the TVT-O technique is a minimal invasive surgery method applied to treat the urinary incontinence surgically, it does not imply that it is a complication-free surgical procedure. Despite the low incidence of intraoperative complications, there is a mild risk of early and late postoperative complications. Fortunately these complications can be taken under control by either conservative and simple medical treatments or surgical procedures.

An assessment of the physical impact of complex surgical tasks on surgeon errors and discomfort: a comparison between robot-assisted, laparoscopic and open approaches.

OBJECTIVES: To evaluate, in a simulated suturing task, individual surgeons' performance using three surgical approaches: open, laparoscopic and robot-assisted. subjects and methods: Six urological surgeons made an in vitro simulated vesico-urethral anastomosis. All surgeons performed the simulated suturing task using all three surgical approaches (open, laparoscopic and robot-assisted). The time taken to perform each task was recorded. Participants were evaluated for perceived discomfort using the self-reporting Borg scale. Errors made by surgeons were quantified by studying the video recording of the tasks. Anastomosis quality was quantified using scores for knot security, symmetry of suture, position of suture and apposition of anastomosis. RESULTS: The time taken to complete the task by the laparoscopic approach was on average 221 s, compared with 55 s for the open approach and 116 s for the robot-assisted approach (anova, P < 0.005). The number of errors and the level of self-reported discomfort were highest for the laparoscopic approach (anova, P < 0.005). Limitations of the present study include the small sample size and variation in prior surgical experience of the participants. CONCLUSIONS: In an in vitro model of anastomosis surgery, robot-assisted surgery combines the accuracy of open surgery while causing lesser surgeon discomfort than laparoscopy and maintaining minimal access.

Low-cost transobturator vaginal tape inside-out procedure for the treatment of female stress urinary incontinence using ordinary polypropylene mesh.

INTRODUCTION AND HYPOTHESIS: The aim of this study is to describe the use of ordinary polypropylene mesh and our modified helical passers through a transobturator vaginal tape inside-out technique (TVT-O) as a low-cost alternative to available commercial kits in the treatment of stress urinary incontinence (SUI) with evaluation of its long-term safety and efficacy. This is important in developing countries due to limited health care resources. METHODS: Tailored (11 × 1.5 cm) polypropylene tape was inserted in 59 women from June 2006 to June 2009 at the Urology Department, Cairo University Hospitals as an open prospective study. SUI was diagnosed by positive cough stress test (CST) and abdominal leak point pressure (ALPP). Patients with post-void residual urine (PVRU) > 100 ml, bladder capacity < 300 ml, or neurological lesions were excluded. The Stress and Urge Incontinence and Quality of Life Questionnaire (SUIQQ), urodynamic parameters, and other variables were compared pre- versus postoperatively with paired t, Wilcoxon signed rank, McNemar, or chi-square tests. RESULTS: The mean age was 47.47 ± 8.52 years. Twenty-one (35.6 %) patients had intrinsic sphincter deficiency (ISD). The mean operative time was 21.22 ± 4.26 min (15-30). Procedures for prolapse were done in four (6 %) patients. Complications were vaginal discharge (6 %), dyspareunia (1 %), groin pain (20 %), urinary tract infection (3 %), obstructive symptoms (1 %), accidental cut of polypropylene suture (1 %) and felt subcutaneous polypropylene sutures (3 %). We had no cases of erosions or de novo urgency. SUIQQ indices improved significantly, while urodynamic parameters showed no significant difference postoperatively. Of the patients, 54 (91 %) were cured and 3 (5 %) improved, while failure was detected in 2 (3 %) patients. CONCLUSIONS: Our technique is safe with excellent 5-year results. It should be considered as a low-cost alternative to available commercial kits in the treatment of SUI mainly for public health systems with few financial resources.